Identification and Traceability Procedure (SYS-032)

Our identification and traceability procedure meets two requirements in ISO 13485:2016 (i.e., Clause 7.5.8 and Clause 7.5.9).

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Identification and Traceability Procedure (SYS-032) and Webinar Bundle

Identification Traceability Procedure Identification and Traceability Procedure (SYS 032)

SYS-032 Identification & Traceability Procedure

Price: $299.00

The purpose of this three-page procedure is to define your company’s requirements for the identification and traceability of lots and serial numbers. This procedure applies to testing samples, raw materials, in-process sub-assemblies, and finished devices. Certain implants may fall under the requirement for Implant Registry Cards by Health Canada, but this is not included in the scope of this procedure (see SYS-037). This procedure is the primary document meeting the applicable regulatory requirements for identification and traceability as defined in your company’s Quality System Manual (POL-001).

What you will receive

SYS-032 A D5 Identification and Traceability

If you would like to ask specific questions about the Identification and Traceability Procedure (SYS-032), please submit them via email or schedule a call using the calendar app on our contact us page. All content deliveries will be sent via AWeber emails to confirmed subscribers. Please check your spam folder if you don’t receive the content automatically.

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About Your Instructor

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.